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Completed

NCT Number: NCT02157389

Psychobiological Mechanisms of Placebo and Nocebo Effects in the Treatment of Chronic Back Pain

Placebo and nocebo responses have mainly been studied in healthy humans for pharmacological rather than psychological interventions. Moreover, only few studies examined patients or tested how previous experience and attitudes affect placebo and nocebo responses. On the psychological level expectancy and classical conditioning have been identified as two primary mechanisms. Both seem to be important with classical conditioning potentially having more long-term effects and expectancy being more important in nocebo effects. There is some initial evidence from the investigators own research that patients may be more prone to these effects and the investigators have also shown that placebo effects may last up to several years after treatment. The investigators therefore examine previous attitudes to pharmacological interventions for chronic pain in patients with chronic back pain and subdivide them into groups with high of low belief in the respective treatment modality. The investigators then apply a pharmacological placebo and study the interaction between the prevailing attitude (implicit and explicit) and the placebo effect with respect to pain perception but also to neurobiological mechanisms using functional magnetic resonance imaging. In addition to expectancy, conditioning of placebo will be examined and the long-term effects of the intervention will be determined.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Institute of Mental Health

Mannheim, 68159, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female human subjects with chronic back pain (chronic persistent and recurrent pain > 6 months)
  • Age between 18 and 65
  • Voluntary participation.

Exclusion criteria

  • Acute or chronic somatic diseases and inflammatory, neuropathic or tumor-related pain
  • Acute and chronic mental disorders according to DSM-IV (except for comorbid anxiety or depression, which are frequent in chronic pain)
  • Insufficient German language skills
  • Cognitive limitations
  • Intake of opioid medication or tranquilizers
  • Metal implants or electric implants that cannot be removed
  • Pregnancy
  • Claustrophobia
  • History of epilepsy, brain trauma, or brain tumor

Treatment and study plan

Administration of a pharmacological placebo

Other

Primary outcomes

  1. Changes in pain intensity and pain unpleasantness ratings after placebo intervention

    Time frame: immediatey to one week

Secondary outcomes

  1. Changes in neuronal activity in response to painful stimulation after placebo administration

    Time frame: immediately

  2. Changes in movement abilities after placebo administration

    Time frame: immediately to one week

Sponsors and collaborators

Lead sponsor

Central Institute of Mental Health, Mannheim

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2014
Registry last updated
Jan 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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